Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Affairs Consultant / CMC薬事コンサルタント
Job ID R0000033984 Ōsaka, JapanCMC Consultant
職務内容:
プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。
業務内容
薬剤開発におけるCMC関連の既存成績並びに情報の分析並びに評価
日本での臨床開発計画及び薬事申請のためのCMC薬事戦略の策定。
製造販売承認申請資料(新規申請、一変申請及び軽微変更届)の作成及び申請。
PMDA相談資料作成及び規制当局との照会事項対応。
申請後の照会事項対応及びPMDAとの対応支援を行い、製造販売承認を取得。
医薬品原薬等登録原簿(MF)及び外国製造業者認定(FMA)手続きの支援
GMP適合性調査サポート
カルタヘナ法に係る申請手続きの支援
医薬品原薬等登録原簿の国内管理人業務(変更管理における薬事評価を含む)
様々な薬事コンサルティング
条件:
製薬会社における医薬品開発(もしくはCROでの勤務)におけるCMC薬事経験3年以上
製薬会社における製剤開発又は分析研究等のCMC研究経験、または製造施設での品質管理(製造管理、分析・試験)等の経験
製造販売承認申請書作成、CTD作成、医薬品原薬等登録原簿の作成などの経験
生物製剤に関するCMC経験者なら、尚可
最終学歴: 大学卒(薬学もしくはその他の自然科学分野の専攻
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